Senior Regulatory Strategy Lead
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Søborg
Can you take the lead and want to work with high-impact projects? Do you want to be part of an ever-changing environment, with numerous ongoing, future projects related to changes within manufacturing of the Novo Nordisk portfolio?
If yes, then you should continue reading and consider becoming part of Novo Nordisk. We are currently looking for a Senior Regulatory Strategy Lead to join our team. Apply now!
The position
Your main responsibility will be to lead the regulatory agenda and plan for ongoing projects involving the expansion of our manufacturing capacity and projects related to changes impacting across products. You will be the point of contact and be responsible for the regulatory strategy, pathway, and opportunities in accordance with regulatory guidelines and requirements.
You will be expected to use your skills to:
In this position, you are expected to demonstrate leadership by setting strategic regulatory direction for high-impact projects in the area and being the strategic partner to stakeholders in the manufacturing organisation and towards the global affiliates.
The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders.
Qualifications
To be successful in this role, you need the following:
In addition to the above, you also need excellent analytical skills, a systematic approach to identify root causes and propose innovative ways to solve problems. You need the ability to communicate complex scientific procedures with technical proficiency both orally and in writing, in a simplified and structured way.
On a personal level, you are a dedicated team player, can build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills.
About the department
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets.
You will be part of a relatively new department responsible for project management, scientific and regulatory strategic input to capacity and manufacturing projects, as well as being responsible for enabling fast approvals for world-wide roll-out and return on investment for the growing manufacturing network.
We are engaged in high potential projects to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For more information, please contact Malene Østergaard Jørgensen at +45 3079 5844.
Deadline
02 January 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
Please briefly explain what motivated you to apply for this role. Include your statement either in CV or Cover Letter, if there is one.
We are looking for several Regulatory Affairs profiles at Novo Nordisk now. Therefore, hiring managers from different teams might also look at your application.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
#LI-AMS1
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Print job Send to e-mail
If yes, then you should continue reading and consider becoming part of Novo Nordisk. We are currently looking for a Senior Regulatory Strategy Lead to join our team. Apply now!
The position
Your main responsibility will be to lead the regulatory agenda and plan for ongoing projects involving the expansion of our manufacturing capacity and projects related to changes impacting across products. You will be the point of contact and be responsible for the regulatory strategy, pathway, and opportunities in accordance with regulatory guidelines and requirements.
You will be expected to use your skills to:
- Lead regulatory agendas, apply intelligence, and develop strategies
- Execute on submission planning and strategies in close collaboration with all relevant stakeholders
- Find new and faster ways of working and obtaining approvals
In this position, you are expected to demonstrate leadership by setting strategic regulatory direction for high-impact projects in the area and being the strategic partner to stakeholders in the manufacturing organisation and towards the global affiliates.
The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders.
Qualifications
To be successful in this role, you need the following:
- Master’s degree in natural science or similar
- Approximately 7-8 years of track record from a similar regulatory position, preferably experienced within CMC (Chemistry, Manufacturing and Controls)
- Work experience with stakeholders, project management and planning
- Proven track-record with FDA (European Medicines Agency), EMA (European Medicines Agency) and other relevant health authorities and processes in other major markets from a global position
- Hands-on experience navigating within an environment of tight timelines, high complexity, non-standards, and diverse tasks in known and new therapy areas
- Advanced level of written and spoken English is required
In addition to the above, you also need excellent analytical skills, a systematic approach to identify root causes and propose innovative ways to solve problems. You need the ability to communicate complex scientific procedures with technical proficiency both orally and in writing, in a simplified and structured way.
On a personal level, you are a dedicated team player, can build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills.
About the department
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets.
You will be part of a relatively new department responsible for project management, scientific and regulatory strategic input to capacity and manufacturing projects, as well as being responsible for enabling fast approvals for world-wide roll-out and return on investment for the growing manufacturing network.
We are engaged in high potential projects to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For more information, please contact Malene Østergaard Jørgensen at +45 3079 5844.
Deadline
02 January 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
Please briefly explain what motivated you to apply for this role. Include your statement either in CV or Cover Letter, if there is one.
We are looking for several Regulatory Affairs profiles at Novo Nordisk now. Therefore, hiring managers from different teams might also look at your application.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
#LI-AMS1
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 28.10.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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